Guo-hua Gao1, Juan Li, Hong-wei Xie, Zhuo Lü. 1. Department of Traditional Chinese Medicine for Rheumatology, Nanfang Hospital, Guangzhou 510515, China. airenaiji924@163.com
Abstract
OBJECTIVE: To evaluate the clinical efficacy of infliximab in the treatment of moderate and severe active rheumatoid arthritis (RA). METHODS: This randomized double-blind II/III clinical trial involved 30 patients with moderate and severe active RA, who were randomly allocated into 3 groups (groups A, B, and C) at the ratio of 3:1:1. At weeks 0, 2, 6, and 14, the patients in groups A and C received infliximab or placebo, and those in group B had placebo at week 14 with a stable background dose of methotrexate. The indicators for efficacy evaluation included the proportions of ACR20/50/70 of the responders and DAS28. The sharp scores of the hand joints were recorded before and after the treatment. RESULTS: Twenty-nine patients completed the clinical trial (18 in group A, 5 in group B, and 6 in group C). At week 14, the proportions of ACR20/50/70 in the 3 groups reached 83.33%, 60%, and 33.33%, respectively (P<0.05), as compared to 100%, 100%, and 33.33% at week 18 (P<0.05). The other indicators for clinical efficacy evaluation also suggested similar clinical improvement of the patients (P=0.000). The proportions of the patients with DAS28<3.2 and DAS28<2.6 were significantly different. Compared to the baseline, the Sharp scores in group A showed no significant changes at week 18 (P>0.930), while those in group C exhibited significant radiographic progression (P<0.044). CONCLUSION:Infliximab produces good short-term therapeutic effect against moderate and severe active RA and may help arrest the radiographic progression of the diseases, which can be more obvious in patients with moderate severity.
RCT Entities:
OBJECTIVE: To evaluate the clinical efficacy of infliximab in the treatment of moderate and severe active rheumatoid arthritis (RA). METHODS: This randomized double-blind II/III clinical trial involved 30 patients with moderate and severe active RA, who were randomly allocated into 3 groups (groups A, B, and C) at the ratio of 3:1:1. At weeks 0, 2, 6, and 14, the patients in groups A and C received infliximab or placebo, and those in group B had placebo at week 14 with a stable background dose of methotrexate. The indicators for efficacy evaluation included the proportions of ACR20/50/70 of the responders and DAS28. The sharp scores of the hand joints were recorded before and after the treatment. RESULTS: Twenty-nine patients completed the clinical trial (18 in group A, 5 in group B, and 6 in group C). At week 14, the proportions of ACR20/50/70 in the 3 groups reached 83.33%, 60%, and 33.33%, respectively (P<0.05), as compared to 100%, 100%, and 33.33% at week 18 (P<0.05). The other indicators for clinical efficacy evaluation also suggested similar clinical improvement of the patients (P=0.000). The proportions of the patients with DAS28<3.2 and DAS28<2.6 were significantly different. Compared to the baseline, the Sharp scores in group A showed no significant changes at week 18 (P>0.930), while those in group C exhibited significant radiographic progression (P<0.044). CONCLUSION:Infliximab produces good short-term therapeutic effect against moderate and severe active RA and may help arrest the radiographic progression of the diseases, which can be more obvious in patients with moderate severity.
Authors: Kalle J Aaltonen; Liisa M Virkki; Antti Malmivaara; Yrjö T Konttinen; Dan C Nordström; Marja Blom Journal: PLoS One Date: 2012-01-17 Impact factor: 3.240